510(k) Report

FDA applicant

Helena Laboratories

Beaumont, TX282 decisions1978–20229 recalls

FDA records 282 decisions for Helena Laboratories (Beaumont, TX) from 1978 to 2022: 282 510(k) clearances. Most are in product codes LCP (Assay, Glycosylated Hemoglobin) and GGP (Test, Qualitative And Quantitative Factor…). Its devices cite 2 predicates, 0 of them its own earlier devices. 9 recalls are linked to its devices.

FDA’s records also spell it “Helena Laboratories, Corp.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Helena Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2007: 12010: 12013: 12022: 2
2007high 2 (2022) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2020

2016: 22017: 12018: 52020: 1
2007high 5 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Helena Laboratories by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LCPAssay, Glycosylated Hemoglobin19decisions
  • GGPTest, Qualitative And Quantitative Factor Deficiency17decisions
  • JHOElectrophoretic Separation, Lipoproteins15decisions
  • CEFElectrophoretic, Protein Fractionation15decisions
  • KHEReagent, Occult Blood12decisions
  • JJYMulti-Analyte Controls, All Kinds (Assayed)11decisions

Also: CFE (11), JBD (11), JPA (8), JJN (8), GGN (7), CGS (7).

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K833611Titan Gel Lipoprotein ElectrophoresisHelena Laboratories · 19842cite it
  • K792507Helena Factor V Deficient SubstrateHelena Laboratories · 19791cites it
  • K933086Afsc Hemo Control #5331, AA2 Hemo Control #5328Helena Laboratories · 19941cites it
  • K941872Specialty Assayed Control-2 Cat. NO. 5302Helena Laboratories · 19941cites it
  • K823870Beta Thalquik Column #5341Helena Laboratories · 19831cites it
  • K935162Rep Direct-Sep Cholesterol-15 Kit; Cholesterol-8 Kit; Cholesterol-4 KitHelena Laboratories · 19941cites it

What has FDA decided for it lately?

  • K213396SPIFE A1AT kitHelena Laboratories, Corp. · 2022
  • K192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlHelena Laboratories, Corp. · 2022
  • K131479V8 SP Normal Control, Abnormal ControlHelena Laboratories · 2013
  • K100103Specialty Assayed Control-2Helena Laboratories · 2010
  • K061991Plateletworks Arachidonic Acid, Model PW-AcaHelena Laboratories · 2007
  • K061069Spife Ife-15 Pentavalent, Model 3456, Spife Ife-9 Pentavalent Kit, Model 3457, Spift Ife-6 Pentavalent Kit…Helena Laboratories · 2006
  • K061014Actalyke QC Kit, Models Aqc-HP and Aqc-LPHelena Laboratories · 20061 recall
  • K050053Hemoram/Aggram AnalyzerHelena Laboratories · 2005

All 280 as Helena Laboratories →All 2 as Helena Laboratories, Corp. →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K061014K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING…Nov 9, 2020Class II
  • K882799ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The…Aug 8, 2018Class II
  • K882799ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The…Aug 8, 2018Class II
  • K910706Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies…May 23, 2018Class III
  • K910706Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies…May 23, 2018Class III
  • K982426SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation…Feb 27, 2018Class III

Other applicant names beginning “Helena”

FDA records each applicant name separately; these may or may not be the same firm.

Helena Laboratories Uk, Ltd. 1